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A Therapeutic Workplace for Alcohol Dependence

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Contingency management
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring contingency management, reinforcement, employment, Therapeutic Workplace

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: meet DSM IV criteria for alcohol dependence are homeless in that they lack a fixed nighttime residence are unemployed are at least 18 years old Exclusion Criteria: are currently physically dependent on opioids are considered in imminent risk of suicide have a psychiatric disorder that is likely to result in behaviors that could disrupt the workplace functioning or limit their ability to provide informed consent are physically unable to perform typing or keypad entry

Sites / Locations

  • Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142

Outcomes

Primary Outcome Measures

percentage of 30 day assessments that subjects reported alcohol abstinence
percentage of heavy drinking days
percentage of positive breath-alcohol tests
percent of patients meeting criteria for current alcohol dependence

Secondary Outcome Measures

percentage of urine samples negative for other drugs
percentage of participants employed each month
days employed per month
employment income per month

Full Information

First Posted
September 13, 2005
Last Updated
May 18, 2010
Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00183144
Brief Title
A Therapeutic Workplace for Alcohol Dependence
Official Title
A Therapeutic Workplace for Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether the Therapeutic Workplace is effective in increasing and maintaining long-term drug abstinence in homeless, alcohol dependent adults.
Detailed Description
Few populations are beset with the constellation of economic, social and health problems that afflict homeless individuals. At the heart of much of this misfortune are staggering rates of alcoholism and drug addiction. While it is not clear whether substance abuse is a cause, consequence, or simply a correlate of homelessness, there is no question that substance abuse is among the most common and most serious problems facing the homeless. Given their unique set of serious and chronic problems, the Institute of Medicine has identified the homeless as a group of people in need of specialized substance abuse interventions. Prior research has shown that the Therapeutic Workplace intervention is effective in the treatment of chronically unemployed heroin and cocaine dependent individuals. The intervention integrates abstinence reinforcement contingencies of proven efficacy into a model supported work program. Under this intervention, patients are paid to perform data entry jobs in the Therapeutic Workplace. Those lacking needed skills are given intensive training in basic academic and job skills. To reinforce abstinence from alcohol and drugs, patients are required to provide an alcohol-free breath sample and drug-free urine sample to gain entrance to the workplace each day. In this way, patients can work and earn salary only when they abstain from alcohol and drugs. Patients are paid in vouchers instead of cash to reduce the chance they will use their earnings to purchase alcohol or drugs. A randomized trial was conducted to evaluate the efficacy of this intervention in homeless, alcohol-dependent adults who completed an inpatient alcohol detoxification. After the detoxification, 124 participants were invited to attend the workplace for 6 months. They were randomly assigned to one of three groups that differed in the requirements for voucher reinforcement. One group received the full therapeutic workplace intervention in which vouchers were contingent on both abstinence and work (Abstinence and Work group). A second group was paid for work, but did not have to provide an alcohol-free breath sample or drug-free urine sample to gain access to the workplace; their vouchers were contingent on work only (Work-Only group). A third group was invited to attend the therapeutic workplace but received no vouchers for work performed or abstinence achieved during treatment (No Voucher group).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
contingency management, reinforcement, employment, Therapeutic Workplace

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Contingency management
Primary Outcome Measure Information:
Title
percentage of 30 day assessments that subjects reported alcohol abstinence
Title
percentage of heavy drinking days
Title
percentage of positive breath-alcohol tests
Title
percent of patients meeting criteria for current alcohol dependence
Secondary Outcome Measure Information:
Title
percentage of urine samples negative for other drugs
Title
percentage of participants employed each month
Title
days employed per month
Title
employment income per month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: meet DSM IV criteria for alcohol dependence are homeless in that they lack a fixed nighttime residence are unemployed are at least 18 years old Exclusion Criteria: are currently physically dependent on opioids are considered in imminent risk of suicide have a psychiatric disorder that is likely to result in behaviors that could disrupt the workplace functioning or limit their ability to provide informed consent are physically unable to perform typing or keypad entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Silverman, PhD
Organizational Affiliation
Johns Hopkins/Center for Learning and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Learning and Health, Johns Hopkins Bayview Medical Campus, 5200 Eastern Ave., Suite W142
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Therapeutic Workplace for Alcohol Dependence

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